Nicorette
- Product NDC
- 0135-0355
- 11-digit product format
- 001350355
- Labeler code
- 0135
- Product ID
- 0135-0355_1f929250-cbfa-d6eb-e063-6394a90a7281
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- nicotine polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- NDA020066
- Marketing category
- NDA
- Marketing start
- 2017-09-13
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0135-0355-03 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-509e-f424-e053-dadaa90a57ce | Drug Facts |
| 0135-0355-03 | 2020-11-16 | C162847 | 48780-1 | 9d75b9d0-509e-f424-e053-dadaa90a57ce | Drug Facts |
| 0135-0355-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-509e-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0355-03 | NicoretteSpearmint Burst | 16 in 1 CARTON | GUM, CHEWING | 16 | 27 | |
| 0135-0355-03 | NicoretteSpearmint Burst | 10 in 1 BLISTER PACK | GUM, CHEWING | 10 | 27 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0355-03 | EA - Each | 0135-0355 | 07268812-b138-4111-bbc7-8da81bd9598c | 1 | 2017-11-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0355 | NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC] | 27 | Current NDC, Legacy NDC, 2 package rows | 20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 209326 | Nicorette 2 MG Chewing Gum | PSN | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 105071 | Nicorette 4 MG Chewing Gum | PSN | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 314119 | nicotine polacrilex 2 MG Chewing Gum | PSN | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 311975 | nicotine polacrilex 4 MG Chewing Gum | PSN | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 209326 | nicotine 2 MG Chewing Gum [Nicorette] | SBD | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 105071 | nicotine 4 MG Chewing Gum [Nicorette] | SBD | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 314119 | nicotine 2 MG Chewing Gum | SCD | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 311975 | nicotine 4 MG Chewing Gum | SCD | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 209326 | Nicorette 2 MG (as nicotine polacrilex 22.2 MG) Chewing Gum | SY | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 209326 | Nicorette 2 MG Chewing Gum | SY | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 105071 | Nicorette 4 MG Chewing Gum | SY | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 314119 | nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing Gum | SY | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
| 311975 | nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing Gum | SY | 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c | 27 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0355-03 | 00135035503 | 16 BLISTER PACK in 1 CARTON (0135-0355-03) / 10 GUM, CHEWING in 1 BLISTER PACK | 16 blister pack | 2017-09-13 | 0000-00-00 | No | No | Current |